Cerebral Infarction
Conditions
Keywords
cerebral infarction, Paralysis, acupuncture, rehabilitation, trial
Brief summary
The purpose of this study is to evaluate the therapeutic effect of acupuncture method of Xing Nao Kai Qiao for paralysis as an apoplectic sequela in a multicenter randomized and controlled clinical trial and to compare the efficacy between acupuncture and rehabilitation therapy. In addition, evaluating the trial in the view of medical economics.
Detailed description
This study is a multi-center randomized controlled trial comparing three treatment groups.The trial is completed in the following three hospitals: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine (TCM) of China, Tianjin Hospital of TCM of China, and Qingdao Haici Medical group of Shangdong province of China. The total observation period within this study is 24 weeks for each patient. All patients should remain hemiplegia within 15～90 days after stroke. After randomization the patients will receive 4 sessions of 30 minutes' duration during a period of 4 weeks. The outcome measurement is completed both in the different times as follows: before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. 288 patients were randomised into three groups: acupuncture group, rehabilitation group,and acupuncture plus rehabilitation group.The patients in the three groups are blinded as to which treatment method they received. The central randomization is used in this trial, which is performed by the Drug Clinical Research Center of Shanghai University of TCM of China. This trial is performed according to the principles of the Declaration of Helsinki (Version Edinburgh 2000). And the trial protocol has been approved by local institutional review board and ethics committee.
Interventions
OTHERacupuncture
Xing Nao Kai Qiao Acupuncture
BEHAVIORALrehabilitation
Kinesitherapy
OTHERacupuncture and rehabilitation
Xing Nao Kai Qiao Acupuncture plus Kinesitherapy
Sponsors
Tianjin University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Cerebral infarction diagnosed according to the diagnostic standard of western medicine 2. Apoplexy diagnosed according to the diagnostic standard of traditional Chinese medicine for apoplexy 3. Cerebral vascular accident occured in the internal carotid artery system which was verified by cerebral CT or MRI 4. The incidence of apoplexy less than twice and the time of onset 15\ 3 months 5. Age: 40-75 years, non-limited gender 6. NDS score of limb functional defect ≥10 7. The patient was alert and the vital signs are stable 8. Participant signed the informed consent form
Exclusion criteria
1. TIA or RIND 2. The nerve function defect induced by the cerebral tumor, trauma, parasitic diseases, heart disease and metabolic disorder or hemorrhagic cerebrovascular disease 3. Pregnant or breast-feeding women 4. Complicated with severe primary disease in heart, liver, kidney and hematology system or psychopath
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score of neurological defect | before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Visualized anologue score | before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. |
| Spasm evaluation | before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. |
| Safety evaluation | before treatment, after the first treatment, 7, 14, 28days after treatment and follow up at 6 months after treatment. |
Countries
China
Contacts
Primary ContactLixin Fu, M.D.
Outcome results
None listed